Journal of substance use and addiction treatment · 2026
Varenicline for nicotine cessation in youth: A meta-analysis of randomized controlled trials addressing FDA labeling gaps in age and product use.
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Park Joo Young, Koh Seong-Joon
Аннотация
INTRODUCTION: This study aims to evaluate the effectiveness and safety of varenicline for nicotine use cessation among young adults, 26 years old or younger. A meta-analysis of Randomized Controlled Trials (RCTs) was conducted.
METHODS: PubMed, EMBASE, and Cochrane Library were searched from the inception to September 25, 2025. Data was pooled using random-effects meta-analysis. The outcome measures were the primary smoking abstinence rate in each study.
RESULTS: Among 247 articles searched, five RCTs were enrolled in the meta-analysis. A total of 717 nicotine users aged from 12 to 26 years were included in the final analysis. Statistically significant increase in abstinence rates was detected with varenicline compared to alternative interventions, such as placebo, bupropion, or nicotine patch (relative risk [RR], 1.99; 95% confidence interval [CI], 1.04-3.80; I2 = 54.6%). Two studies specifically compared varenicline with bupropion or nicotine patch, and Bucher's method was applied to adjust the comparison to varenicline against placebo. Statistically significant increase in abstinence rates was also detected compared to placebo (odds ratio [OR], 2.93; 95% confidence interval [CI], 1.01-8.49; I2 = 70.3%). The safety of varenicline was comparable to placebo considering treatment-emergent adverse events, or alternative pharmacological interventions considering treatment discontinuation adverse events.
CONCLUSIONS: This meta-analysis suggests that varenicline can be actively considered for promoting early smoking cessation in young adults. The findings provide a rationale for initiating clinical trials to further evaluate its efficacy and safety in adolescents, and they support the potential application of varenicline for cessation among young e-cigarette users as well.
METHODS: PubMed, EMBASE, and Cochrane Library were searched from the inception to September 25, 2025. Data was pooled using random-effects meta-analysis. The outcome measures were the primary smoking abstinence rate in each study.
RESULTS: Among 247 articles searched, five RCTs were enrolled in the meta-analysis. A total of 717 nicotine users aged from 12 to 26 years were included in the final analysis. Statistically significant increase in abstinence rates was detected with varenicline compared to alternative interventions, such as placebo, bupropion, or nicotine patch (relative risk [RR], 1.99; 95% confidence interval [CI], 1.04-3.80; I2 = 54.6%). Two studies specifically compared varenicline with bupropion or nicotine patch, and Bucher's method was applied to adjust the comparison to varenicline against placebo. Statistically significant increase in abstinence rates was also detected compared to placebo (odds ratio [OR], 2.93; 95% confidence interval [CI], 1.01-8.49; I2 = 70.3%). The safety of varenicline was comparable to placebo considering treatment-emergent adverse events, or alternative pharmacological interventions considering treatment discontinuation adverse events.
CONCLUSIONS: This meta-analysis suggests that varenicline can be actively considered for promoting early smoking cessation in young adults. The findings provide a rationale for initiating clinical trials to further evaluate its efficacy and safety in adolescents, and they support the potential application of varenicline for cessation among young e-cigarette users as well.